NC TREK 1012454-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 08717648152108), received between Sep 29, 2016 and Apr 29, 2026 — classified as 18 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (48 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method

  THE PATIENT PRESENTED WITH PERSISTENT RESIDUAL STENOSIS IN THE PROXIMAL AND MID SEGMENTS OF THE RIGHT CORONARY ARTERY AFTER STENT IMPLANTATION. THE PROCEDURE PERFORMED WAS TO TREAT THE RIGHT CORONARY ARTERY. THE 4.50X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS NOTED NOT TO BE PREPPED OUTSIDE THE ANATOMY PRIOR TO USE. THE BDC WAS ADVANCED AND THE BALLOON WAS INFLATED ONCE TO 16 ATMOSPHERES; HOWEVER, AFTER MULTIPLE ATTEMPTS THE BALLOON ONLY PARTIALLY DEFLATED. THE NC TREK BDC WAS SLOWLY WITHDRAWN, AND THE BALLOON WAS STUCK AT THE TIP OF THE GUIDING CATHETER. ALL DEVICES WERE REMOVED AS A SINGLE UNIT AND THE PROCEDURE WAS ABORTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25034950 ↗
• MalfunctionJan 12, 2026Failure to Fold; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 4.50X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED TO 8 ATMOSPHERES (ATM) HOWEVER AFTER DEFLATION, THE BALLOON COULD NOT REFOLD COMPLETELY. RESISTANCE WAS MET WITH THE GUIDING CATHETER THEREFORE THE BDC WAS WITHDRAWN ALONG WITH THE ENTIRE SYSTEM. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24039495 ↗
• MalfunctionDec 15, 2025Entrapment of Device; Failure to Fold; Difficult to Remove; Entrapment of Device; Failure to Fold; Difficult to Remove

  SUBSEQUENT TO THE INITIALLY FILED REPORTS IT WAS STATED THAT NO ADDITIONAL DEVICES WERE USED TO HELP REMOVE THE BALLOON. THE BALLOON WAS REMOVED AS A UNIT WITH THE GUIDING CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23811730 ↗
• MalfunctionNov 18, 2025Break; Deflation Problem; Improper or Incorrect Procedure or Method; Break; Deflation Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MILDLY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY THAT IS 80% STENOSED. THE 4.50X12MM NC TREK BALLOON DILATATION CATHETER COMPLETELY FAILED TO DEFLATE, WAS WITHDRAWN PARTIALLY DEFLATED, AND THE SHAFT WAS NOTED TO BE CRACKED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584916 ↗
• MalfunctionNov 14, 2025Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Deflate; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Deflate

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, IT WAS NOTED THAT THE DEVICE WAS NOT PREPPED (AIR ASPIRATED) OUTSIDE THE ANATOMY. ADDITIONALLY, ON (B)(6) 2025, PAIN, SWELLING AND NUMBNESS WAS OBSERVED IN THE PATIENT'S HAND. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Numbness; Pain; Swelling/ Edema

  MAUDE report 23560181 ↗
• MalfunctionNov 5, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 80% STENOSIS. THE NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED AND UPON REMOVAL THERE WAS RESISTANCE WITH THE GUIDING CATHETER. THE SHAFT SEPARATED DURING REMOVAL TOGETHER WITH THE ARTERIAL SHEATH. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER SAME SIZE NC TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23481742 ↗
• InjuryJun 9, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A SEVERELY STENOSED LESION IN THE DIAGONAL ARTERY. AFTER STENT IMPLANTATION, POOR EXPANSION WAS OBSERVED AT THE PROXIMAL END OF THE STENT. A 4.5X12MM NC TREK BALLOON DILATION CATHETER (BDC) WAS USED TO POST-DILATE THE STENOTIC SEGMENT; HOWEVER, AFTER BALLOON INFLATION AND COMPLETE DEFLATION, THE BALLOON COULD NOT BE RETRACTED. SUBSEQUENTLY, ANOTHER DEVICE WAS USED TO PUNCTURE THE BALLOON, AND IT WAS RETRIEVED USING A GUIDING CATHETER. A NEW BALLOON OF THE SAME MODEL WAS THEN USED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167571 ↗
• MalfunctionMay 6, 2025Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING ARTERY. THE 4.50X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED TO 20 ATMOSPHERES FOR POST DILATATION OF A PREVIOUSLY UNSPECIFIED STENT. THE BDC BECAME STUCK WITH AN UNSPECIFIED STENT IN THE LEFT MAIN AND AND WHEN ATTEMPTING TO REMOVE THE PROXIMAL SHAFT OF THE BDC SEPARATED. THE SEPARATED PORTION REMAINED STUCK ON THE GUIDE THEREFORE, EVERYTHING WAS REMOVED AS A ONE UNIT INCLUDING THE SEPARATE PORTION. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21969227 ↗
• InjuryJan 23, 2025Deflation Problem; Failure to Fold; Difficult to Remove; Material Separation; Deflation Problem; Failure to Fold; Difficult to Remove; Material Separation

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 4.50X12MM RX NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR POST DILATATION OF AN IMPLANTED STENT. THE BALLOON WAS INFLATED ONCE TO 12 ATMOSPHERES HOWEVER COULD NOT BE COMPLETELY DEFLATED AND THE BALLOON WOULD NOT REFOLD. DURING WITHDRAWAL RESISTANCE WAS MET AND THE SHAFT SEPARATED WITH THE DISTAL PORTION LEFT IN THE GUIDING CATHETER. A SNARE WAS USED TO RETRIEVE THE SEPARATED PORTION. ANOTHER SAME SIZE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217513 ↗
• InjuryApr 9, 2024Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  SUBSEQUENT TO THE INITIALLY FILED MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED. THE NC TREK BALLOON WAS INFLATED TO 22 ATMOSPHERES WHICH IS ABOVE THE RATED BURST PRESSURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19070871 ↗
• InjuryDec 12, 2023Deflation Problem; Entrapment of Device; Deflation Problem; Entrapment of Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (PRCA) WITH 80% STENOSIS. THE 4.5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED 3 TIMES UP TO 14 ATMOSPHERES (ATMS) AND NEGATIVE WAS HELD FOR 10 SECONDS. THE BALLOON WAS USED FOR DILATATION AND MOLDING AFTER A 4.0X23MM NON-ABBOTT STENT WAS IMPLANTED. THE BDC COULD NOT BE RETRACTED SINCE IT COULD NOT BE COMPLETELY DEFLATED AND MULTIPLE WITHDRAWALS WERE ATTEMPTED. THE BALLOON COULD NOT BE BURST AT 30 ATMOSPHERES (ATMS) WHEN SUSPENDED INTO RIGHT CORONARY SINUS. A NON-ABBOTT GUIDE WIRE WAS USED TO PUNCTURE THE BALLOON AND THEN PULLED OUT OF THE ANATOMY TOGETHER WITH THE GUIDING CATHETER ENDING THE PROCEDURE. THE PATIENT DID NOT COMPLAIN OF DISCOMFORT DURING THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELAE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311441 ↗
• InjuryNov 13, 2023Difficult to Remove; Material Separation; Failure to Advance; Difficult to Remove; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MILD CALCIFICATION. THE 4.50X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS A BEING ADVANCED AND BECAME STUCK DUE TO THE LESION. DURING REMOVAL, THE SHAFT SEPARATED AND A SNARE DEVICE WAS USED TO RETRIEVE THE SEPARATION BALLOON MATERIAL IN THE GUIDE CATHETER. THERE WAS A 2 HOURS DELAY IN THE PROCEDURE; HOWEVER, THERE WAS NO HARM TO THE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18121781 ↗
• MalfunctionSep 7, 2023Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Deflate; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Deflate

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING ARTERY. THE 4.5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WOULD NOT DEFLATE. THE BDC WAS NOTED TO BE STUCK IN THE ANATOMY WHEN ATTEMPTING TO REMOVE; HOWEVER, WITH EXTRA FORCE THE BDC WAS REMOVED FULLY INFLATED. IT WAS NOTED THAT THE DEVICE WAS NOT SOAKED PRIOR TO USE. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17703431 ↗
• MalfunctionAug 28, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (MLAD). THE 4.50X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED; HOWEVER, DURING REMOVAL THERE WAS RESISTANCE WITH THE GUIDING CATHETER AND THE SHAFT WAS NOTED SEPARATED BUT REMAINED INSIDE THE CATHETER. THE BDC AND GUIDING CATHETER WERE REMOVED TOGETHER AS ONE UNIT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED AN INNER AND OUTER MEMBER SEPARATIONS; HOWEVER, THE ACCOUNT CONFIRMED THAT THEY WERE AWARE OF THE SEPARATION AND SINCE THE SEPARATED PARTS WERE REPORTED AS RETURNED NOTHING WAS LEFT INSIDE THE PATIENT'S ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17632286 ↗
• InjuryJul 7, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). THE LESION WAS STENTED WITHOUT ISSUE, AFTER WHICH A 4.50X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED FOR DILATATION. IT IS UNKNOWN HOW MANY TIMES THE BALLOON WAS INFLATED OR TO WHAT ATMOSPHERES FOR EACH INFLATION. DURING REMOVAL FROM THE RCA, THE BALLOON BECAME STUCK IN THE ARTERY AND COULD NOT BE PULLED OUT. FORCE WAS NOT APPLIED, HOWEVER THE BALLOON SEPARATED AT THE SHAFT SOLDER JOINT. AN NC BALLOON WAS THEN ADVANCED TO THE SEPARATED TREK BALLOON IN THE RCA AND INFLATED. UPON DEFLATION OF THE NC BALLOON, THE BALLOON FOLDS GRABBED ONTO THE SEPARATED NC TREK BALLOON AND PULLED IT OUT OF THE ANATOMY WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED AT THAT POINT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278757 ↗
• InjuryJun 5, 2023Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN AN UNSPECIFIED ARTERY. THE 4.5X12MM NC TREK RX BALLOON DILATATION CATHETER (BDC) SHAFT FRACTURED AND SEPARATED INTO TWO PIECES. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED MDR, THE FOLLOWING INFORMATION WAS PROVIDED: THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL CIRCUMFLEX (CX) ARTERY WITH 95% STENOSIS, NO CALCIFICATION AND NO TORTUOSITY. THE 4.5X12MM NC TREK RX BALLOON DILATATION CATHETER (BDC) HAD NO RESISTANCE DURING ADVANCEMENT AND POST DILATATION WAS COMPLETED. THERE WAS RESISTANCE NOTED DURING WITHDRAWAL TOWARDS THE GUIDE CATHETER AT THE LOCATION OF THE COMMON TRUNK AND MILD FORCE WAS APPLIED. THE SHAFT FRACTURED AND SEPARATED INTO TWO PIECES AT ABOUT 15CM FROM THE DISTAL END. THE "TWISTING WIRES" TECHNIQUE WAS APPLIED AND RETRIEVED THE SEPARATED PIECE FROM THE ANATOMY. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059292 ↗
• MalfunctionMay 2, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY THAT IS 99% STENOSED. THE 4.5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED FOR POST-DILATATION; HOWEVER, WHEN REMOVING THE BALLOON IT WOULD NOT PASS THROUGH THE UNSPECIFIED CATHETER. THE BALLOON AND THE UNSPECIFIED GUIDE CATHETER WERE REMOVED AS A SINGLE UNIT AS THE SHAFT SEPARATED AND REMAINED IN THE GUIDE CATHETER. THE BALLOON WAS CRIMPED UP AGAINST THE RADIAL SHEATH THEREFORE, THE SHEATH WAS REMOVED AND THE REMAINING PORTION WAS REMOVED. RESISTANCE WITH THE RADIAL SHEATH WAS NOTED DURING REMOVAL. NO OTHER DEVICE WAS USED AS POST-DILATATION WAS SUCCESSFULLY COMPLETED WITH THE BALLOON. THERE WAS NO ADVERSE PATIENT EFFECTS REPORTED AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16854069 ↗
• MalfunctionApr 24, 2023Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT MAIN (LM) ARTERY. THE 4.5X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS USED TO DILATE A STENT. HOWEVER, THE BALLOON COULD NOT BE PULLED BACK INTO THE GUIDING CATHETER. THERE WAS WRINKLING AND BLOCKAGE OF THE CATHETER SO THE ENTIRE GUIDING CATHETER WITH THE BALLOON WAS REMOVED. HOWEVER, THE WHOLE SYSTEM COULD NOT GET THROUGH THE INTRODUCER SHEATH AND DUE TO THE PULLING, THE BALLOON CATHETER WAS TORN. BALLOON, GUIDING CATHETER AND THE ENTIRE INTRODUCER SHEATH WERE REMOVED TOGETHER. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16795957 ↗
• MalfunctionFeb 9, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY THAT WAS MODERATELY CALCIFIED. DURING REMOVAL FROM THE ANATOMY WITH RESISTANCE, THE NC TREK RX PROXIMAL SHAFT SEPARATED OUTSIDE THE PATIENT, BUT DEVICE WAS SUCCESSFULLY REMOVED. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16342668 ↗
• MalfunctionJan 11, 2023Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CHRONIC TOTAL OCCLUSION IN THE RIGHT CORONARY ARTERY (RCA). PRE-DILATATION WAS PERFORMED USING A 2.5 X 30 MM OTW TREK, THEN A 4.0 X 38 MM NON-ABBOTT STENT WAS IMPLANTED IN THE MID RCA AND A 4.0 X 12 MM NON-ABBOTT STENT WAS IMPLANTED AT THE PROXIMAL RCA. POST DILATATION WAS PERFORMED WITH THE 4.5 X 12 MM NC TREK. THE BALLOON WAS INFLATED TO 12 ATMOSPHERES (ATM) AND A RUPTURE OCCURRED. THE DEVICE WAS UNABLE TO BE REMOVED; THEREFORE, IT WAS REMOVED AS A SINGLE UNIT WITH THE GUIDE CATHETER AND GUIDE WIRE. IT WAS NOTED THAT THE PROXIMAL NON-ABBOTT STENT STRETCHED, AND IT WAS THOUGHT THAT THE STENT HAD CAUGHT ON THE BALLOON AS IT WAS REMOVED. THE GUIDE CATHETER, GUIDE WIRE AND BALLOON WERE ALL REMOVED AND NO PORTION OF THE BALLOON REMAINED IN THE ANATOMY. ADDITIONAL INTERVENTION WAS REQUIRED TO PLACE A THIRD NON-ABBOTT STENT TO CRUSH THE STRETCHED STENT TO THE VESSEL WALL. POST DILATATION WAS PERFORMED USING A NON-ABBOTT DILATATION CATHETER. A DELAY WAS REPORTED, AS THE VESSEL NEEDED TO BE RE-WIRED; HOWEVER, NO ADVERSE PATIENT EFFECT WAS REPORTED DUE TO THE BALLOON RUPTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16142417 ↗
• MalfunctionDec 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION, NO TORTUOSITY AND 90% STENOSIS. A 3.5 MM NON-ABBOTT BALLOON WAS USED FIRST AND THEN THE 4.5X8 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED TO 12 ATMOSPHERES (ATM) ON THE SECOND INFLATION FOR FIVE SECONDS. WHEN INFLATED TO 18 ATM, THE BDC RUPTURED. A 4.5X12MM NC TREK BDC WAS USED AS A REPLACEMENT AND DURING THE FIRST INFLATION FOR 5 SECONDS THE BALLOON RUPTURED. THE NC TREK WAS REPLACED WITH A NON-ABBOTT BDC TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16023821 ↗
• InjuryNov 23, 2022Entrapment of Device; Stretched; Entrapment of Device; Stretched

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE OSTIAL RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. THE LESION WAS PREPARED WITH ROTABLATION AND A 4.0X12 MM XIENCE STENT WAS SUCCESSFULLY IMPLANTED. AFTER POST-DILATION OF THE STENT WITH THE NC TREK BALLOON DILATATION CATHETER (BDC) FOR 2 INFLATIONS AT 16 ATMOSPHERES, THE STENT WAS CONFIRMED TO BE APPOSED TO THE VESSEL WALL WITH INTRAVASCULAR ULTRASOUND (IVUS). THERE WAS RESISTANCE DURING REMOVAL; HOWEVER, THE BALLOON WAS NOTED TO BE FULLY DEFLATED. THE MARKERS OF THE BALLOON DID NOT MOVE WHILE WITHDRAWING THE CATHETER SO THE DEVICE WAS STRETCHING. THE NC TREK BALLOON WAS TRAPPED WITH A 2.5X12 MM TREK BDC AND REMOVED ALONG WITH THE GUIDE CATHETER. THE STENT WAS THEN POST-DILATED WITH A NON-ABBOTT NC BALLOON. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15855282 ↗
• InjuryNov 9, 2022Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15762341 ↗
• InjuryNov 7, 2022Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS A PROXIMAL OPTIMISATION TECHNIQUE (POT) TO TREAT A LESION IN THE LEFT MAIN (LM) ARTERY WITHOUT CALCIFICATION AND MILD TORTUOSITY. THE 4.5X12MM NC TREK RX BALLOON DILATATION CATHETER (BDC) ADVANCED WITHOUT RESISTANCE AND WAS INFLATED AT 14 ATMOSPHERES (ATMS). THERE WAS RESISTANCE DURING REMOVAL AND THE TIP OF THE CATHETER WAS TORN OFF [SEPARATED] BUT REMAINED IN THE CATHETER. FORCE WAS APPLIED. THE SEPARATED TIP TOGETHER WITH THE GUIDE CATHETER AND GUIDE WIRE WERE REMOVED AS A UNIT BY ANCHORING THE DISTAL PART WITH ANOTHER SMALLER BALLOON INSIDE THE GUIDING CATHETER. THERE WAS NO ADVERSE PATIENT SEQUELA AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15748262 ↗
• MalfunctionOct 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. AFTER IMPLANTATION OF A XIENCE STENT, THE 4.50 X 12MM NC TREK WAS ADVANCED TO THE STENTED LESION FOR POST-DILATATION. DURING THE FIRST INFLATION TO 14 ATMOSPHERES, THE BALLOON RUPTURED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15596768 ↗